Feasibility study of an objective randomized blinded investigation of therapeutic ablation versus cardioversion for persistent Atrial Fibrillation (ORBITA-AF).
Trial objective: Feasibility study of an objective randomized blinded investigation of therapeutic ablation versus cardioversion for persistent Atrial Fibrillation (ORBITA-AF)
Disease area: Cardiac Arrhythmia
Status: In set-up
Chief Investigator: Prof Richard Schilling
Principal Investigator: Dr Malcolm Finlay
Sponsor: Barts Health NHS Trust
Funder: Barts Charity / MEDTRONIC
The study is investigating how best to treat patients with atrial fibrillation and who are being considered for treatment to try and restore the normal heartbeat. This is important because at the moment, patients with irregular heart rhythms often will be recommended to have an electric shock procedure (Cardioversion) to try and re-establish a normal rhythm. However, this often does not work in the long term without many patients continuing on strong medications to try and maintain a normal heart rhythm.
Catheter ablation is a newer technique that is often used if patients go back into AF and which several studies have shown higher rates of maintaining normal heart rhythm than Cardioversion. But studies have not so far been performed to see if catheter ablation is better than Cardioversion for certain patients.
Patients with atrial fibrillation who are considered suitable to have either a cardioversion or ablation procedure will be invited. They will be implanted with a minaturised long-term injectable cardiac monitor to record heart rate and rhythm continuously. Patients will be randomised to either Cardioversion or Cardioversion plus Catheter Ablation. On discharge, patients will be seen at the Outpatient clinic and heart rhythms will be monitored regularly.
Sample size and duration
20 patients, with recruitment taking place at Barts over a period of 6 months.
For further information about the study, please contact a member of the research team:
Tel: +44(0) 20 3765 8635